Suppliers / Kyowa Kirin

Kyowa Kirin

Japan Updated 9 July 2026

Kyowa Kirin is a finished-dose manufacturer based in Japan. It appears in 148 regulatory filings across 21 regulators, without an active US DMF or CEP on file. Its filings concentrate with SFDA (Saudi Arabia), Health Canada and MHRA (UK). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 14 December 2022 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
148
filings across 21 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 14 December 2022 VAI US FDA
  • 11 December 2018 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Hoofddorp, United Arab Emirates Not on file
Genève, Switzerland Not on file
GALASHIELS, United Kingdom Not on file
TAKASAKI, Japan Not on file
Japan, Japan 3007588904
Hoofddorp, Netherlands Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
SFDA (Saudi Arabia) 15 None
Health Canada 15 None
MHRA (UK) 14 None
EMA 13 2
AIFA (IT) 11 None
NPRA (MY) 11 None
ANVISA (Brazil) None 1

Questions about Kyowa Kirin

Does Kyowa Kirin hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Kyowa Kirin. It does have 148 filings with 21 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Kyowa Kirin FDA-registered?
One site operated by Kyowa Kirin carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Kyowa Kirin's last inspection go?
The most recent inspection on record closed on 14 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Kyowa Kirin manufacture?
7 registered sites are on record, in United Arab Emirates, Switzerland, United Kingdom and Japan (Hoofddorp, Genève and Galashiels among others). Every site is listed on this page with the register it came from.
Which regulators recognise Kyowa Kirin's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 December 2022.

Comparable suppliers

Bushu Pharmaceuticals also in Japan Chugai Pharma Manufacturing also in Japan Eisai also in Japan Hisamitsu Pharmaceutical also in Japan Lead Chemical also in Japan

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates